NCT01053806

Safety And Efficacy Of Azacitidine, and Lenalidomide In Higher Risk Myelodysplastic Syndrome

A PHASE 2, SINGLE ARM STUDY TO DETERMINE THE SAFETY AND EFFICACY OF AZACITIDINE, AND LENALIDOMIDE IN HIGHER RISK MYELODYSPLASTIC SYNDROME

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the overall response rate of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients (INT-2 and High risk defined by IPSS), and patients with low and int-1 who are considered to be at high risk due to unfavorable additional factors. * To evaluate the safety of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients. * To evaluate the hematological improvement rate. * To evaluate the cytogenetic response rate. * To evaluate the Progression free survival (PFS). * To assess Quality of life.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	5-Azacytidine and Lenalidomide	Induction:5-Azacytidine 75mg/m2/d S.C.or I.V. days 1-5 every 28 days a cycle for 6 cycles and Lenalidomide 10mg/d orally days 6-28 every cycle for 6 cycles Consolidation: 5-Azacytidine 75mg/m2/d S.C.or I.V. days 1-5 every 28 days for 6 cycles Maintenance: Lenalidomide 10mg/d orally days 1-21 every cycle of 28 days for 13 cycles.

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-03-01
• First posted: 2010-01-21
• Last updated: 2012-09-25

Locations

1 site across 1 country: Israel